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Image display of Automated Breast Ultrasound (ABUS), as well as other multi-modality DICOM medical images for diagnostic and non-diagnostic review purposes. The device will be used by trained healthcare professionals.

The Invenia ABUS Viewer is intended for the image display of breast ultrasound images. The Invenia ABUS Viewer can received, transmit, and display medical images and associated patient medical information from the Invenia ABUS Scan Station as well as from other ultrasound or image acquisition devices.

The provided text is a 510(k) premarket notification summary for the GE Healthcare Invenia ABUS Viewer. It details the device's indications for use, its classification, and its substantial equivalence to predicate devices. However, this document explicitly states:

"The subject of this premarket submission, Invenia ABUS Viewer, did not require clinical studies to support substantial equivalence."

This means that the information needed to answer many of the questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in the provided document, as no clinical studies were performed for this submission. The device is a "viewer" for medical images, not an AI or diagnostic algorithm itself, which often do not require clinical performance studies for 510(k) clearance if they are found to be substantially equivalent to predicate devices based on technological characteristics and intended use.

Therefore, I cannot provide a detailed response to the majority of your questions about acceptance criteria and study details because the submission states no clinical studies were required or performed to demonstrate performance against specific criteria.

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